People around the world frequently suffer from upper respiratory tract and oral pharyngeal congestion. This congestion may be caused by allergies, infections in the respiratory tract and/or oral and pharyngeal cavities, changes in weather conditions, as well as from the overall health and genetic disposition of the person. This congestion is generally diagnosed from partially or fully blocked air passages including airways in the lungs, mouth, nose, and throat. Other symptoms related to the cause typically accompany the congestion. Cough, tickles in the throat, cold symptoms such as fever, flu, sinus infections, and throat or gland pain are some of the more common symptoms found with upper respiratory and oral pharyngeal congestion.
Congestion of the upper respiratory tract and oral pharyngeal cavity and related symptoms generally have undesirable effects for the afflicted person. For example, the congestion may affect performance in the workplace, school, and at home up to and including loss of work and loss of school attendance. Further, congestion may reduce the ability to perform routine activities, such as housework, driving, running errands, and may even totally incapacitate the person. Severe and intolerable congestion often requires visits to the hospital and treatment. In addition, viral or bacterial infections of the sinus passage or other airway may be passed to healthy persons through symptoms of the congestion. For example, a cough or sneeze may convey a bacterium or virus to another person. Thus, upper respiratory tract and oral pharyngeal congestion and its symptoms need to be treated.
Generally, there are two typical approaches to treating symptoms of the congestion. One approach involves initially treating the underlying cause of the symptom. For example, a bacterial infection is generally treated by administering an antibiotic to kill the bacteria causing the infection. The second approach involves treating the symptoms themselves, typically in addition to treating the underlying cause, by independently administering one or more medications for relief of specific symptoms. For example, an antitussive agent, commonly referred to as a cough suppressant, has been typically administered for the treatment or relief of cough. An opioid medication, such as codeine and hydrocodone bitartrate, has generally been administered to relieve pain consistent with the congestion while suppressing a cough. Also decongestants, such as phenylephrine and pseudoephedrine, have been administered to both children and adults in flavored formulations for reducing mucosal swelling and draining the mucus build-up to clear congestion in the air passages. Symptoms due to allergies or allergens are often treated with an antihistamine. Antihistamines, often referred to as histamine-class receptor blockers, are compounds that may antagonistically block the histamine receptor from binding histamine thereby preventing the symptoms of an allergy. Examples of antihistamines include brompheneramine maleate, chlorpheneramine maleate, and diphenhydramine, all of which have shown good clinical efficacy.
There are many different treatment medications utilizing a combination of agents in therapeutic doses for treating multiple symptoms of upper respiratory tract and oral pharyngeal congestion. As one example, a single medication may include an expectorant, in combination with an antitussive agent, for removing phlegm or mucus that may have accumulated in the lungs and other air passages in addition to suppressing a cough. The expectorant is helpful in preventing the progression of a mild case of bronchitis to a more severe case of pneumonia. As another example, an opioid medication such as hydrocodone bitartrate may be combined with a decongestant, such as phenylephrine, to provide relief from congestion and discomforts related to the congestion. In addition, antihistamines may be included with the opioid and the decongestant in a single medication. For example, chlorpheniramine may be included as an antihistamine with hydrocodone and phenylephrine in a single medication.
Combination therapy provides many benefits. For example, it allows patients suffering from congestion and related symptoms to take only a single dosage medication, as opposed to multiple medications, for relief therefrom. Further, it enhances compliance in accordance with a regimen by eliminating the need for the patient to take different medications. To this end, combination therapy provides convenience, ensures compliance, and saves cost.
Combined treatment medications may be formulated as syrups, pills, tablets, and capsules. Formulations may include flavoring agents to mask undesirable flavors or tastes from desired medicinal agents and colorants to render the medication more attractive and appealing to the eye. For example, many formulations have a raspberry, cherry, orange, or grape flavor well liked by both children and adults. Moreover, these flavors are easily identified by their color. In combination formulations, the individual ingredients are included in amounts proven to be effective to treat targeted symptoms. Effective amounts have varied depending on the particular formulation, type and degree of the symptoms, and desired user or consumer. For example, a child's dose of an elixir or syrup for the relief of cough and pain related to congestion may have the antitussive and analgesic in reduced quantities based on size, weight, and age of the child targeted, comparable to a composition or formulation for an adult which may have double the dosage of the antitussive and analgesic.
Accordingly, it is desirable to have an administrable composition to reduce symptoms of upper respiratory tract and oral pharyngeal congestion. It is further desirable that the composition be effective in reducing cough, congestion, histamine-stimulated allergy symptoms and related pain. Still further, it is desirable for the composition to contain dosages suitable for administration to a child as well as an adult. In addition, it is desirable to have the composition in a convenient and pharmaceutically acceptable dosage form.